Z-2416-2015Class II

ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of...

Name: Z-2416-2015 ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-06-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-06-30 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium... on 2015-06-30. FDA classified it as Class II and gives the reason as "A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2416-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2015-08-19
Terminated: 2016-09-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. Siemens Healthcare Diagnostics is conducting a voluntary recall for the ADVIA Chemistry Acetaminophen reagent, for all in date and future kit lots. Customers were informed of the revised interference levels of N-acetyl cysteine (NAC) of 200 mg/dL, for the ADVIA Chemistry Acetaminophen assay. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions call 1 (800) 441-9250.
Quantity in commerce: 1032
Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
Product codes and lots: Catalog Number 07989138, Siemens Material Number (SMN) 10327381, Lot Numbers: 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558; with expiration dates June 30, 2015 through April 30, 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2416-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2416-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code LDP

K100200Class IIAdvia Chemistry Acetaminophen Reagent, Model Ref 07989138Siemens Healthcare Diagnostics / cleared 2010-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)